Stress Urinary IncontinenceNCT06261736
The Effectiveness of Prophylactic Antibiotics for Urethral Bulking
A study testing Prophylactic antibiotics and No antibiotics in people with Stress Urinary Incontinence and Postoperative Urinary Tract Infection, run by Atlantic Health System at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate if prophylactic antibiotics in urethral bulking are effective in reducing postprocedural urinary tract infections. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence, Postoperative Urinary Tract Infection, Urethral Bulking
- What is being tested?
- Prophylactic antibiotics and No antibiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2023to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo a urethral bulking procedure
- Age 18 ≥ over
Who cannot join
- History of recurrent urinary tract infections
- Known history of urinary retention
- Allergies or contraindications to multiple antibiotics
- Inability to tolerate oral antibiotics
- Concomitant surgical procedures at the time of urethral bulking
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Atlantic Health
Morristown, New Jersey, 07960
Tess Gao, MD, 9739717267, tess.gao@atlantichealth.org
Erika Wasenda, MD
About this study
The goal of this clinical trial is to evaluate if prophylactic antibiotics in urethral bulking are effective in reducing postprocedural urinary tract infections.
Read the detailed description
Urethral bulking is a minimally invasive surgical treatment option for stress urinary incontinence (SUI). One commonly reported post-procedural complication is urinary tract infection (UTI). UTI rates are variable where studies have reported rates from as low as 0% to as high as 40%. Along with this variability, the instructional inserts for various bulking agents have inconsistent recommendations for use of prophylactic antibiotics. The American Urologic Association recommends antimicrobial prophylaxis for cystourethroscopy procedures involving minor manipulation. Currently, there are no clear guidelines regarding the utility of prophylactic antibiotics for urethral bulking. The objective of our study is to determine the effectiveness of prophylactic antibiotics in urethral bulking for reducing post procedural UTIs.
- Being tested
- Prophylactic antibiotics, No antibiotics
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic antibioticsOther
These participants will be given a single dose of an oral antibiotic prior to the procedure.
No antibioticsOther
These participants will not be given an antibiotic prior to the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic Group | Experimental | Those randomized to this group will receive a one-time dose of an oral antibiotic prior to the urethral bulking procedure. The antibiotic will be based on the participants' allergies, medical history, and current medication list. Receives: Other: Prophylactic antibiotics |
| No antibiotic group | Other | Those randomized to this group will not receive an antibiotic prior to the urethral bulking procedure. Receives: Other: No antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of urinary tract infection (UTI)
The rate of UTI based on symptoms and a positive urine culture
Measured: Within 4 weeks after the procedure
Secondary outcomes (2)
Rate of postoperative urinary retention
The rate of postoperative urinary retention
Measured: Within 4 weeks after the procedure
Rates of other postoperative complications
The rate of other complications (bleeding, discomfort, etc)
Measured: Within 4 weeks after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start24 Oct 2023
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erika Wasenda, Atlantic Health System
- Investigators
- Erika Wasenda, MD, Principal investigator, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261736
- Sponsor's protocol ID
- 2107044-1
- Status last verified
- Apr 2025
- First submitted
- 8 Feb 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Prophylactic Antibiotics for Urethral Bulking
- ClinicalTrials.gov ID
- NCT06261736
- Acronym / sponsor ID
- 2107044-1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate if prophylactic antibiotics in urethral bulking are effective in reducing postprocedural urinary tract infections.
Detailed description
Urethral bulking is a minimally invasive surgical treatment option for stress urinary incontinence (SUI). One commonly reported post-procedural complication is urinary tract infection (UTI). UTI rates are variable where studies have reported rates from as low as 0% to as high as 40%. Along with this variability, the instructional inserts for various bulking agents have inconsistent recommendations for use of prophylactic antibiotics. The American Urologic Association recommends antimicrobial prophylaxis for cystourethroscopy procedures involving minor manipulation. Currently, there are no clear guidelines regarding the utility of prophylactic antibiotics for urethral bulking. The objective of our study is to determine the effectiveness of prophylactic antibiotics in urethral bulking for reducing post procedural UTIs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic Group | Experimental | Other: Prophylactic antibioticsThose randomized to this group will receive a one-time dose of an oral antibiotic prior to the urethral bulking procedure. The antibiotic will be based on the participants' allergies, medical history, and current medication list. |
| No antibiotic group | Other | Other: No antibioticsThose randomized to this group will not receive an antibiotic prior to the urethral bulking procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled to undergo a urethral bulking procedure
- Age 18 ≥ over
Key exclusion criteria (6 listed)
- History of recurrent urinary tract infections
- Known history of urinary retention
- Allergies or contraindications to multiple antibiotics
- Inability to tolerate oral antibiotics
- Concomitant surgical procedures at the time of urethral bulking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prophylactic antibioticsThese participants will be given a single dose of an oral antibiotic prior to the procedure. | Other | Antibiotic Group |
| No antibioticsThese participants will not be given an antibiotic prior to the procedure. | Other | No antibiotic group |
Primary outcome
Rate of urinary tract infection (UTI)
Time frame: Within 4 weeks after the procedure
The rate of UTI based on symptoms and a positive urine culture
2 secondary outcomes
Rate of postoperative urinary retention
Time frame: Within 4 weeks after the procedure
Rates of other postoperative complications
Time frame: Within 4 weeks after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erika Wasenda, MD principal investigator
Atlantic Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic antibiotics and No antibiotics in people with Stress Urinary Incontinence and Postoperative Urinary Tract Infection, run by Atlantic Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tess Gao, MD (973-971-7267, tess.gao@atlantichealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of urinary tract infection (UTI) (time frame: Within 4 weeks after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.